Recall Z-1718-2019 ยท HRS Plate, Fixation, Bone
I.T.S. GmbH
Rim Plate, 10-Hole, Left, PRS RX System. Titanium, implantable - Product Usage: The implant temporarily stabilizes bone segments until bony consolidation has taken place. After this, the implant has no more use and can be removed.
| Date | May 9, 2019 |
| Status | Open, Classified |
| Reason | The titanium implant has the wrong article number laser marked on it. |
| Root cause | Labeling mix-ups |
| Action | I.T.S. GmbH notified international consignees initially on about 05/09/2019, via an updated "Urgent Notice MEDICAL DEVICE RECALL" letter, and US customers were notified to quarantine affected devices. On about 05/13/2019, US customers were notified via an updated "Urgent Notice MEDICAL DEVICE RECALL" letter. Customers were instructed to immediately review their inventory to identify and remove all affected products listed above in a manner that ensures the affected products will not be used, review, complete, sign and return the attached reply form and send it back within 5 business days |
| Quantity | 65 devices |
| Distribution | Worldwide distribution - US nationwide distribution in the states of Florida and Puerto Rico, and countries of Austria, Netherlands, Slovenia, South Africa, Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063166 | I.T.S. PELVIC RECONSTRUCTION SYSTEM I.T.S. Implantat-Technologie-Systeme GmbH, Dec 22, 2006 |